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The article doesn't mention which HIV meds come off patent over the next couple of years, but from what I've seen from other articles, the drugs below come off patent by 2013 (or at least the first patent expires by these dates). It's possible that in some cases the patents will be extended.

I've wondered what will happen when certain drugs come off patent-- if insurance companies will start "encouraging" people to switch to certain drug regimens due to cost-- (which is already the case for most other conditions... where a doctor has to jump through insurance hoops to get a new drug covered for a patient when there is an existing treatment the insurance company believes is equivalent)

Take Atripla, which is approximately the same cost as Sustiva + Truvada currently- I wonder if the bean counters will start pushing people to take Truvada + the generic efavirenz when it becomes available instead of Atripla...

There's no way Prezista is on that list, it was just FDA approved five years ago.

I've spent some time trying to get a handle on how this works, but patent law is a bit odd and keeps changing.

For drugs, the law is right in the middle of a transition period. The general rule used to be that patents expired 17 years after approval. But for applications filed after 1995 the rule is that patents expire 20 years after the date of filing. Since 1995 + 17 is 2012 there is a lot of potential for confusion just for starters, but in theory all that can be cleared up by looking in the FDA's Orange Book which lists patent expiration dates.

It gets even more complicated though, since companies that can demonstrate a pediatric use get an extra 6 month extension. Also multiple patents claims get filed on modest product changes in order to extend the date of patent expiration, but some of those product changes matter and some don't. Its very hard to figure out from the Orange Book which patent claims will matter.

And then, just because the patent expires doesn't mean there will be a generic available. Generics have to be approved by the FDA. There's a cost for that, and for fending off patent lawsuits from the original manufacturer. So the potential generic manufacturer has to see a big enough market opportunity to make it worth their while. When the patent on Lipitor expires you can be pretty sure there will be a generic right away, because Lipitor raked in more money than any other drug last year. But the manufacturer of Epzicom has publicly stated that the patents on its components have expired and there are no US approved generics yet.

The FDA Orange book lists all the patents and most of the Prezista patents expire by 2016. So it is possible it could go generic relatively quickly. But whether it will or not seems hard to tell.

Expediting the approval of US generics seems like it could be a way to increase access to HAART dramatically and fix a lot of the ADAP funding problems.

There is also another strange thing that I learned about generics (whether it applies here or not I do not know)

One a generic manufacturer enters in talks with the original maker (under FDA or patent loss pressure or for whatever reason) they may get awarded an exclusive rights , of a duration of 6 months, during which they can develop/manufacture/submit to FDA.

If they fail to do so at month 7, their exclusive right is revoked.

I think it happenned in one case where the original manufacturer granted the rights to a company which remained idled for 6 months. If I remember properly it was even suspected that they had remained idle under pressure or illicit agreement with the original maker (eventhough they claimed they faced unexpected financial difficulties)

Here the use of generics for this type of meds is not allowed (because the patent is still active)

Once the patent ends, then, it might be possible that generics are made available.

In our socialized health care, this is what I found out: (this is how it works where I live, not valid for the US and other places)

- the patient has a right to ask for a generic or the original as he/she wishes (doctor or pharmacist can suggest but not impose)

So far so good.

BUT, I also found out that in case the pharmacists offers a generic and the patient accepts, then it makes a big difference for the pharmacist:

because the generic is cheaper, they earn less...

In order to compensate for that the legal margin that they are allowed to make is:6 % for 'normal' approved medicinebut 23 % for generics !

Depending on the generic list price, your trusted pharmacist may have a vested interest in suggesting a generic (sometimes, saying that they have it on stock whereas you may have to wait 1 day for your preferred original)

MORE ...

It has just been decided that DOCTORS will get a yearly bonus for prescribing generics.

So not only the pharmacist but the doctors themselves will have some vested interests.

For our meds I do not know if this will apply.

But IMHO, while the active molecule is the same, the encapsulation formulation which allows delayed release requires a lot of know how and if it where me only I would prefer to stick to the original.

This may help explain why Epzicom which is multi layered, coated, etc. is not manufactured as a generic. I do not know for sure

Not so sure about that. My immediate reaction was actually in the article. Read all the way to the bottom.

"Such lawsuits are common to clarify patent rights while the FDA separately considers the generic-drug applications"

Eric mentions there has been some controversy about patent holders potentially colluding with the holder of the first generic license to delay production ... the health care reform bill had some language that was supposed to take care of that but I haven't heard whether it did or not.

You're right Miss Philicia. Prezista's patent expires in 2019. I had looked at a couple of medical sites that put the expiration at 2012, and they appeared to have the right dates for the other meds. I guess I should have done more fact checking. My bad.

So you honestly think that an HIV med approved in 2006 is going to come off patent in 2016... k You know, viread hasn't even appeared in generic form yet in the US.

If I had much money in my pocket I'd be willing to bet against you.

It is very difficult to tell what will happen with any specific drug, because it depends on whether generic manufacturers want to make it and how much lawsuit agony they are willing to put up with and how good the new patent claims are...

Here it looks like the choices are 2016 or 2019 (although the Orange Book lists one claim all the way out to 2026). If Teva wins in court it will probably be 2016.

But specific drugs aside, there has been a lot of analysis saying that the 1995 law will change things pretty dramatically for the drug companies. For some drugs that take a long time to get approved, the time being sold under patent will be a lot shorter than it used to be.

Does the fact that they released Viramune XR have any impact on the drug going generic? Would the generic version only be the old formulation and would the XR variety still be name brand or would that also go generic?

Does the fact that they released Viramune XR have any impact on the drug going generic? Would the generic version only be the old formulation and would the XR variety still be name brand or would that also go generic?

XR is a different formulation, so different patents, this is the same as Truvada/Sustiva vs Atripla.

I think the drug makers can file for extensions. Usually only after better more effective drugs come along and the older drugs are seldom used, then the older drugs can turn generic or lower cost. Look at sustiva for example, sustiva was combined with truvada into a new drug Atripla. That new drug starts the clock ticking all over again as to patent even though sustiva and truvada individually are older drugs. Atripla containing two older drugs is now considered a new drug. Go figure...

Does the fact that they released Viramune XR have any impact on the drug going generic? Would the generic version only be the old formulation and would the XR variety still be name brand or would that also go generic?

There is considerable (and perhaps informed) speculation that the release of Viramune XR was partly an effort to have a drug to move people on to after the regular Viramune goes generic. Its a pretty common pharma trick to get a patentable drug to sell (even the XR name)

^^The clock starts over for the new drug atripla. I don't think it starts all over for Sustiva or any of the drugs the comprise atripla. Please correct me if im wrong anyone.

When all the drugs that make up atripla go generic, sales of atripla will probably plummet drastically as folks opt to buy generic truvada and generic sustiva. This will most def gelt be the case if one can get this generics for $4 one month supply or $10 for 90 day supply like it's done here at Kroger and HEB in Texas.

I'm on Atripla and while I am happy to take one pill a day, if sustiva and truvada become generic it would be a huge weight lifted. I worry now about running out of meds, or losing my insurance or what have you and having to either pay 2 grand a month or buy it from India. It would be great having a local generic. Even if its not one pill.

"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts